Manufacturing ExpansionThe strategic collaboration with Minaris Advanced Therapies enhances US-based manufacturing capabilities and brings the scalability needed for NurOwn's complex autologous cell therapy.
Regulatory ApprovalThe FDA clearance for the upcoming P3b study in amyotrophic lateral sclerosis positions BrainStorm to acquire funds to conduct the trial, including non-dilutive sources such as a $15M grant and potential strategic partnerships.
Therapeutic EfficacyNurOwn is the most advanced therapy in the ALS space, is safe, and has a history of positive therapeutic impact, making the trial crucial for patients and caregivers.